Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia

Established since 2001

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Manufacturing Facility in Kulim, Kedah

First Regionally Owned Manufacturer of APIs in Malaysia and ASEAN Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia

Core Activity

Research Development & Manufacture of Active Pharmaceutical Ingredients Symbiotica Speciality Ingredients Sdn. Bhd. Accreditation, Certification and Filings Malaysia

PIC/S - ICH Q7A GMP CERTIFICATION - NPRA, MALAYSIA

US FDA - INSPECTED AND ACCEPTED FACILITY

COFEPRIS, MEXICO - GMP CERTIFICATION

EDQM CERTIFICATE OF SUITABILITY - 8 PRODUCTS, 2 UNDER EVALUATION

US DMF - 8 FILED, 10 MORE BEING FILED

REPHINE, UK PHARMASSES GMP

MNC - APPROVED SUPPLIERS TO GSK, SANOFI, TAKEDA, MYLAN, STADA, TEVA

IS0 9001:2008 CERTIFICATION - BUREAU VERITAS CERTIFICATION The Beginnings Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia

- Period of Establishment. 2000 - 01 : - Development. - Commercialisation ( 1 kg Batches ). - Pioneer status. 2002 - 03 : - Scale up ( 5 kgs Batches ). - Expansion & upgrading works ( Grade D Cleanroom of class 100 K ). - GMP certification - ICHQ7A-PIC/S and WHO. 2004 - 06 : - ISO Certification. - First CEP application. - Export Excellence Award ( MITI - MATRADE ). - Enterprise 50 awards - 6th Position ( SME corp - Delloite Malaysia). 2007 - 09 : - First CEP awarded from EDQM - for Dexamethasone Sodium Phosphate. - More CEP applications - for additional produtcs began.

- First Major expansion on existing site by addition of adjacent buildings, raising of work space height - Scale up ( 20 kgs batches ). A separate facility for non-steroidal API was set up on the same site. 2010 - 12 : - - Three major MNC supply audits and commercial contracts. - US market developmental efforts - filing of US DMFs. - Awarding of more CEPs.

- First US FDA inspection took place by mid 2014 which was successful & entry into the USA market - Cofepris GMP certified. 2013 - 17 : - New site of 15.14 acres was acquired at the nearby Kulim High Tech Park & additional industrial buildings in Taman Industri Waja for the future growth strategy. - Additional CEP filings and DMF compilations made. Symbiotica Symbiotica Today Speciality Ingredients Sdn. Bhd. Malaysia

Turnover of USD 17 Million approx.

Manufacturing nearly 40 APIs in batch sizes of 1 kg - 100 kgs.

85 % of revenue contributed by exports, one of the largest exporters from the Malaysian Pharmaceutical Industry.

Market presence in over 50 countries worldwide : Asia-pacific, Middle east, Russia, Balkans, Africa, Maghreb, Western EU, Eastern EU, North America, Central America, Latin America etc.

GMP certified as per the ICH Q7 A guidelines by NPRA, Malaysia, a PIC/S member country, qualified to provide written confirmation as per new EC directive.

Successfully inspected and accepted by the US FDA in July 2014.

Cofepris GMP certified.

Audited regularly by MNCs, EU clients, Independent EU audit agencies & other overseas clients.

Hold 8 CEPs & filed 8 US DMFs.

Winner of 2 awards – EXPORT EXCELLENCE from MITI & ENTERPRISE 50 from SME Corp.

Regular participant in International Pharma fairs.

Team of 80 people. Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia

Philosophy

Believe in Symbiosis, Function with Specialization & Synergy, Deliver Ingredients with Quality, Serve with Excellence, Live with passion ! Make the world Happy, Healthy & lively, as a Life Sciences Company. Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia

Core Competence

Quality Trust Service Flexibility Reliability Competitiveness Symbiotica Speciality Ingredients Sdn. Bhd. Quality Department Malaysia

Regulatory Quality Quality Validation Assurance Control Affairs Symbiotica Speciality Ingredients Sdn. Bhd. Quality Management System Malaysia

Pharmaceutical Inspection Cooperation Scheme ( PIC/S ) / ICH Q7A Certified by National Pharmaceutical Regulatory Agency Malaysia

ISO 9001: 2008 Certified by Bureau Veritas Quality International

QMS managed and implemented through a 5 Step Plan

International Certification Client Audits/ Local Regulatory Internal Audit Regulatory Audit Vendor Audits Audits Audit Symbiotica Quality Assurance Speciality Ingredients Sdn. Bhd. Malaysia

Responsible for Quality Management system and batch release Ensures Compliance towards ICH Q7A GMP & ISO 9001:2008 Conducts Training & retraining to ensure that personnel follow SoPs Efects Surveillance audits to enforce QMS & GMP Carries out Annual Internal Audits & Management Review Documentation preparation, implementation, review and control. Designs & implements procedures related to validation involving process, cleaning procedures, equipment qualification, utility qualification. Regulatory document management in terms of preparation, submission, registration, review of Drug Master Files as well as responding to regulatory queries from regulatory authorities and customers. Approval, filing and review of change controls, deviations, CAPAs, etc. Management of Annual Product Review, Customer Complaints & Investigation when necessary. Issuance & Review of Batch Manufacturing Records. Preparation and maintenance of Master Protocol such as SoP list & Validation Protocol Management of Vendor Qualification. Symbiotica Filing of Speciality Ingredients Sdn. Bhd. Regulatory Drug Master files Malaysia Common Technical Documents Affairs Technical Packs

RA US DMFs CEP/COS RA RA

BETAMETHASONE VALERATE BETAMETHASONE VALERATE BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CLOBETASOL PROPIONATE BETAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE Registration with CLOBETASOL PROPIONATE HALOBETASOL PROPIONATE authorities, DEXAMETHASONE SODIUM PHOSPHATE HYDROCORTISONE VALERATE Answering of MOMETASONE FUROATE MOMETASONE FUROATE queries of PREDNISOLONE ACETATE EXEMESTANE authorities & TIBOLONE customers APPLIED : EXEMESTANE TESTOSTERONE PROPIONATE Symbiotica Manufacturing Site - Current Speciality Ingredients Sdn. Bhd. Malaysia

Steroidal Block

10 Mts/Annum

Multiproduct Site

Non-Steroidal Block

Kulim, Kedah, Malaysia 20 Mts/Annum Symbiotica Speciality Ingredients Sdn. Bhd. Manufacturing activity Malaysia

Facility is spread over 27,000 sqft (2,500 m2 ) land area with 2 separate manufacturing blocks for Steroidal and Non-Steroidal APIs. Centralized warehouse is located inside a separate building.

Raw materials are subjected to quarantine, sampling & QC release prior to dispensing in separate and dedicated Down-Flow Booths prior to transfer for production.

Production involves various chemical synthetic steps involving reaction, distillation, extraction, separation etc., which are carried out in the Crude Chemical area. This area is equipped with Reactions Vessels made of Stainless Steel, Mild-Steel-Glass-Lined, Full-Glass, etc. Condensers, Centrifuges, Neutsche Filters, Sparkler Filter, Tray Dryers, etc.

Final Powder Processing is carried out in a ISO Class 8 Clean-Room involving Drying, Milling, Micronization, Blending, Packing etc. Equipments used in this area are Tray Dryers, Vacuum Tray Dryers, Rotary Cone Vacuum Dryers, Blenders, Mills and Micronizers. Packing is carried out only after final QA batch release. In-Process Quality Control ensures adherence to standard procedures for consistent Quality under GMP compliance

Plant utilities involve Huber Temperature Control Systems, Chillers, Nitrogen Generator, Vacuum Pumps, DI water system, Scrubber, Evaporative Ventilation Systems, Exhausts, Air-Handling Units etc. Symbiotica Speciality Ingredients Sdn. Bhd. Facility Layout Malaysia

519 518 517

Non-Steroidal Chemical Area Steroidal Chemical Area

Centralized Warehouse Non-Steroidal Common Powder Zone Steroidal Powder Processing Area Processing

QC-Int QC-W Symbiotica Manufacturing Sites Speciality Ingredients Sdn. Bhd. Malaysia

Site I : Current

Address 518, Jalan Waja 4, Taman Industri Waja, 09000, Kulim, Kedah

Size 27,000 sft

Certifications NPRA - ICH Q7A : PIC/S GMP certification ( Last inspection - Sep’15 )

US FDA - successfully inspected and accepted ( Last inspection - July’14 )

Site II : New - Green Field

Address Lot 4, Industrial Zone Phase 2, Kulim Hi-tech Park, 09000, Kulim, Kedah

Size 15.14 acres ( 659,498.4 sft )

Certifications -

- Symbiotica Location of the the Sites Speciality Ingredients Sdn. Bhd. Malaysia

Current Site

New Site Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia

Symbiotica - II

Kulim Hitech industrial estate Targeted date of completion : End 2018 15.14 Acres / 612700 sqm / 659499 sqft Symbiotica Speciality Ingredients Sdn. Bhd. Proposed Activities at the New Green Field Site Malaysia

Sterile Steroidal API - Crystallized / Lyophilized

Non-steroidal API Block

Additional Steroidal & Hormonal API Blocks

Steroid Intermediate Blocks

Fermentation Block

Phytochemical R&D and Industrial facility Symbiotica Speciality Ingredients Sdn. Bhd. Our Values Malaysia

Associate with a spirit of Symbiosis towards mutually beneficial co-existence in all Symbiosis spheres - Internally & Externally

Customized solutions in terms of tailoring quality, packaging, sterilization, analysis etc to suit customer needs. Impurity profile, Particle size distribution etc are = Customization customizable.

Very high level of reliability achieved through Prompt responsiveness, Maintenance of Reliability ample inventory levels, Secure QMS, Timely deliveries etc.

Responsible approach towards servicing of client’s regulatory needs, effective & empathetic handling of customer feedbacks, successfully undergoing audits with an open & transparent attitude, etc have contributed Trustability towards a very strong factor of trust amongst clientele. Symbiotica Speciality Ingredients Sdn. Bhd. Epilogue Malaysia

An experiment that Metamorphosed to a rich & great experience.

Challenges of operating an API manufacturing company in Malaysia have been successfully met.

Global reputation as a major player in the steroidal API field and one of the few companies that produces Pinaverium Bromide ( Non-steroidal API ).

First Asian company to obtain CEP for Dexamethasone Sodium Phosphate – first one to get it after Sanofi and Pfizer.

First Asian company to obtain CEP for Tibolone and the second in the world after an Italian mfr.

Approved supplier to major MNCs – GSK, Sanofi Aventis, Takeda, Mylan, Stada, Teva Symbiotica Speciality Ingredients Sdn. Bhd.

BECLOMETHASONE DIPROPIONATE * Malaysia BETAMETAMETHASONE ACETATE BETAMETHASONE DIPROPIONATE *+ BETAMETHASONE SODIUM PHOSPHATE * BETAMETHASONE VALERATE *+ S BUDESONIDE CLOBETASOL PROPIONATE *+ ProductsText with CLOBETASONE BUTYRATE T CLOSTEBOL ACETATE REGULATORY Package DEFLAZACORT * CEP DEXAMETHASONE SODIUM PHOSPHATE *+ E + US DMF DROSPIRENONE * CEP under application EXEMESTANE *+ Others – CTD available R HALOBETASOL PROPIONATE + HYDROCORTISONE BUTYRATE HYDROCORTISONE HEMI SUCCINATE * O HYDROCORTISONE VALERATE + METHYL PREDNISOLONE ACEPONATE I METHYL PREDNISOLONE HEMI SUCCINATE * Customizations : MOMETASONE FUROATE *+ PREDNICARBATE * Micronization D Terminal Sterilization : PREDNISOLONE ACETATE * Gamma radiation @ 10-15 KGY PREDNISOLONE HEMI SUCCINATE Dose S PREDNISOLONE PIVALATE PREDNISOLONE SOD. METASULFOBENZOATE PREDNISOLONE SODIUM PHOSPHATE * TESTOSTERONE PROPIONATE TIBOLONE * Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia

DIFLORASONE DIACETATE S DESONIDE DEXAMETHASONE DIMETHYL BUTYRATE DEXAMETHASONE DIPROPIONATE Products which can T DEXAMETHASONE ISONICOTINATE be upgraded to DEXAMETHASONE PALMITATE REGULATORY E DEXAMETHASONE PHENYL PROPIONATE Package against DEXAMETHASONE PIVALATE committed projects DEXAMETHASONE SOD. METASULFOBENZOATE with potential R DEXAMETHASONE VALERATE partners FLUMETHASONE PIVALATE FLUOCINONIDE O HYDROCORTISONE ACEPONATE HYDROCORTISONE BUTYRATE PROPIONATE I METHYL PREDNISOLONE ACETATE PREDNISOLONE VALERATE ACETATE Customizations : TRIAMCINOLONE ACETONIDE D TRIAMCINOLONE DIACETATE Micronization Terminal Sterilization : TRIAMCINOLONE HEXAACETONIDE Gamma radiation @ 10-15 KGY S TRILOSTANE Dose Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia

NON-STEROIDS

PINAVERIUM BROMIDE

Supported with REGULATORY Package in terms of a CTD format DMF ( ASMF, EDMF ). Audited by COFEPRIS, Mexico. Symbiotica Speciality Ingredients Sdn. Bhd. US FDA - Products with DMF Numbers Malaysia

PRODUCT US DMF NO. BETAMETHASONE DIPROPIONATE 24486

BETAMETHASONE VALERATE 27210

CLOBETASOL PROPIONATE 24015

DEXAMETHASONE SODIUM PHOSPHATE 24215

EXEMESTANE 25275

HALOBETASOL PROPIONATE 30906

HYDROCORTISONE VALERATE 31423

MOMETASONE FUROATE 26153 US FDA - NDC Listed products Symbiotica Speciality Ingredients Sdn. Bhd.

PRODUCT NDC NO. Malaysia Beclomethasone Dipropionate 52128-128-01 Betamethasone Acetate 52128-131-01 Betamethasone valerate 52128-125-01 Betamethsone Dipropionate 52128-123-01 Betamethsone Sodium phosphate 52128-124-01 Clobetasol Propionate 52128-121-01 Deflazacort 52128-135-01 Dexamethasone Sodium phosphate 52128-122-01 Exemestane 52128-134-01 Halobetasol propionate 52128-138-01 Hydrocortisone butryate 52128-130-01 Hydrocortisone valerate 52128-136-01 Methylprednisolone Aceponate 52128-139-01 MethylPrednisolone Acetate 52128-148-01 Mometasone Furoate 52128-126-01 Pinaverium bromide 52128-137-01 Prednicarbate 52128-129-01 Prednisolone Hemi Succinate 52128-149-01 Prednisolone sodium phosphate 52128-127-01 Testosterone Propionate 52128-142-01 Tibolone 52128-146-01 Triamcinolone Acetonide 52128-143-01 Triamcinolone diacetete 52128-145-01 Triamcinolone Hexacetonide 52128-144-01 Symbiotica Speciality Ingredients Sdn. Bhd. EDQM - Product/CEP Numbers Malaysia

PRODUCT CEP / COS NO.

BETAMETHASONE DIPROPIONATE R0-CEP 2011-005-Rev 00

BETAMETHASONE SODIUM PHOSPHATE R0-CEP-2013-326-Rev 00

BETAMETHASONE VALERATE R1-CEP 2008-215-Rev 00

CLOBETASOL PROPIONATE R1-CEP 2009-221-Rev 00

DEXAMETHASONE SODIUM PHOSPHATE R1-CEP 2006-184-Rev 00

MOMETASONE FUROATE R1-CEP 2009-313-Rev 00

PREDNISOLONE ACETATE R0-CEP-2014-138-REV 00

TIBOLONE R1-CEP 2010-294-Rev 00 Symbiotica Speciality Ingredients Sdn. Bhd. Malaysia

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